BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA XL

    MDR report key: 2896693 · Received November 20, 2012

    Report

    Report Number
    1220063-2012-00065
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 29, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DESPITE UPGRADING THE SOFTWARE TO (B)(4) IN (B)(4) 2012, THERE ARE STILL PROBLEMS WITH SPO2 MEASUREMENTS. THE MONITOR IS USED WITH THE (B)(4). FIRST, DESPITE SHOWING A WAVEFORM, THERE ARE NO VALUES INDICATED, ONLY AFTER TURNING DOWN OR UNPLUGGING THE USB. SECONDLY, WITHOUT A PT CONNECTED, BUT WITH THE SENSOR (NEONATAL) HANGING IN THE AIR, VALUES ARE SHOWN. THIRD, WHEN THERE IS NO PT CONNECTED, THE ALARM IS REPEATEDLY GENERATED AND IT IS NOT POSSIBLE TO QUIT IT ONLY ONE TIME. THERE WAS NO PT INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO